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SOTIO Biotech
30/12/2021
October 2021 Review of news from the most innovative therapeutic areas and the business development transactions
Market
US House Democrats continue to seek consensus on drug pricing
Nasdaq Biotech Index lost3 % during October. Democrats are scrambling to find a way to include drug price control measures in Build Back Better Act after Medicare drug price setting measures were dropped from compromise legislation released by White House and House Democrats.
Antibody-Drug Conjugates
Preclinical stage Pyxis Oncology completed IPO with post-money valuation of $524 million
Third ADC candidate with Synaffix’ technology enters clinic as Miracogen initiated Phase 1
Shanghai Miracogen’s ADC partnership with Synaffix is paying off as MRG-004A, an ADC designed to treat solid tumors, has entered US Phase 1/2 to treat solid tumors. It marks the third ADC candidate developed with Synaffix's Glycoconnect technology that has entered clinical development. MRG-004A is currently being developed for TF-positive advanced or metastatic solid tumors. Chinese Miracogen is responsible for the research, development, manufacturing and commercialization of the ADC product, while Synaffix is responsible for the manufacturing of components that are specifically related to its Glycoconnect and Hydraspace technologies. MRG-004A is an ADC targeting human tissue factor, conjugated using Glycoconnect site specific conjugation technology. It was selected for clinical development based on highly competitive efficacy and tolerability in preclinical studies compared to conventional ADC technology.
Interleukin-15 and Interleukin-2
Alkermes initiated Phase 3 evaluating nemvaleukin alfa combined with Keytruda in ovarian cancer
Alkermes announced the initiation of ARTISTRY-7, a global Phase 3, open-label, randomized trial evaluating the anti-tumor activity and safety of intravenously administered nemvaleukin alfa, in combination with Keytruda, compared to investigator's choice chemotherapy, in patients with platinum-resistant ovarian cancer.
Nemvaleukin, Alkermes' lead immuno-oncology candidate, is a novel, investigational, engineered IL-2 variant immunotherapy. As previously announced, ARTISTRY-7 is being conducted in collaboration with Merck & Co, which is providing Keytruda for the study. In addition, Alkermes is working with The GOG Foundation and ENGOT to conduct the study. FDA recently granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.
Cell Therapies
FDA’s speed kills Agenus’ BLA application for PD-1 inhibitor balstilimab
FDA approved Tecartus as first and only CAR-T for relapsed or refractory B-cell ALL
Kite and Gilead announced the FDA has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only CAR-Tcell therapy approved for adults with ALL. There is a high unmet need, as half of this patient population will relapse, and median OS is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the US.
Other Innovative Treatment Areas
Innovent’s PD-1 inhibitor meets primary endpoint in Phase 3 NSCLC study
Innovent Biologics’ Phase 3 Orient-31 trial for sintilimab in EGFR-mutated nonsquamous NSCLC met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar) and chemotherapy, the treatment improved PFS vs. chemotherapy alone. The Orient-31 study looked into sintilimab plus Byvasda and chemotherapy as a treatment for disease that has progressed after treatment with an EGFR tyrosine kinase inhibitor.
Patients were randomized in a 1-to-1-to-1 ratio to receive the sintilimab/Byvasda/chemo combo therapy, sintilimab plus combined with chemotherapy (pemetrexed and cisplatin), or placebo combined with pemetrexed and cisplatin. The study continues until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Target accrual is 480 patients. The study showed no additional safety signals. Sintilimab in combination with chemotherapy demonstrated a trend of PFS benefit compared to chemotherapy alone.
Oncology Transactions
Takeda to acquire GammaDelta Therapeutics to develop γδ T cell therapies
M&As
Takeda to acquire GammaDelta Therapeutics to develop γδ T cell therapies
Takeda announced the exercise of its option to acquire GammaDelta Therapeutics Limited, a company focused on exploiting the unique properties of γδ T cells for immunotherapy. Through the acquisition, Takeda will obtain GammaDelta’s allogeneic variable delta 1 γδ T cell therapy platforms, which includes both blood-derived and tissue-derived platforms, in addition to early-stage cell therapy programs.
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